The Adult Antiretroviral Treatment and Resistance Study (Tshepo)

This study has been completed.

Sponsor:

Harvard School of Public Health

ClinicalTrials.gov Identifier:

NCT00197613

First Posted: September 20, 2005

Last Update Posted: September 17, 2012

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The "Adult Antiretroviral Treatment and Resistance Study," hereafter referred to as "The Tshepo Study," is the first large-scale research study of antiretroviral therapy to treat AIDS and HIV infection in Botswana. The Tshepo Study is an open-label, randomized study comparing: (1) the rate of development and specific types of drug resistance mutations with various antiretroviral combination therapies to HIV-1C, the subtype of HIV found in southern Africa, and (2) the short and long-term effectiveness of two operational modifications of Directly Observed Therapy (DOT) medication adherence strategies for antiretroviral therapy. Specifically, treatment follow-up via the Standard of Care, the national standard of care as it evolves in Botswana, with intensive clinic-based follow up including regular adherence education sessions, will be compared to Community-Based Directly Observed Therapy (Com-DOT). Com-DOT involves the SOC with added community or family-based DOT. This Com-DOT component would involve a trained, community or family-based Medication Partner ("mopati") who observes the patient take his or medications daily.

Further study details as provided by Richard Marlink, Harvard School of Public Health:

Primary Outcome Measures:

Time to Virological failure, time to grade 3 or higher toxicity.

Secondary Outcome Measures:

Time to drug resistance, rates of point mutations at virological failure, adherence to study medication.

Estimated Enrollment:

650

Study Start Date:

December 2002

Study Completion Date:

December 2007

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:(1) HIV infection indicated by (a) positive ELISA in two separate blood samples, the second no more than eight weeks prior to randomization), (b) CD4 cell count of less than 200 cells/ml OR CD4 cell count between 201-350 with plasma HIV-1 RNA level of greater than 55,000 copies/ml, (c) Karnofsky (performance) score greater than or equal to 50; (2) no history of previous antiretroviral therapy, except for zidovudine and/or single-dose nevirapine administered during pregnancy to prevent mother-to-child HIV transmission of HIV-1; (3) baseline hemoglobin of greater than or equal to 8.0 g/dl (4) baseline absolute neutrophil count greater than or equal to 1000 cells/mm3 (5) baseline serum creatinine level less than 200 micromol/L (6) baseline SGPT(ALT) less than 205 U/L and SGOT (AST) less than 170 U/L (7) baseline alkaline phosphatase level less than or equal to 330 U/L etc.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00197613

Locations

Botswana

Princess Marina Hospital

Gaborone, Botswana

Sponsors and Collaborators

Harvard School of Public Health

Princess Marina Hospital, Botswana

Botswana Ministry of Health

McGill University Health Center

Bristol-Myers Squibb

Investigators

Principal Investigator:

Richard Marlink, MD

Harvard School of Public Health AIDS Initiative

More Information

Responsible Party:

Richard Marlink, Professor of the Practice of Public Health, Harvard School of Public Health